Leadership

News Release

ROCKVILLE, Md.--(BUSINESS WIRE)--Apr. 22, 2014--
Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has
initiated manufacturing of BioThrax® (Anthrax Vaccine
Adsorbed) consistency lots in Building 55, following review by the U.S.
Food and Drug Administration (FDA) of the Manufacturing and Non-Clinical
Study Protocols submitted by the company supporting the Building 55
comparability program. The goal of the comparability program is to
generate data that will show BioThrax manufactured at large scale in
Building 55 is comparable to the BioThrax currently manufactured in the
approved facility, Building 12. BioThrax is the only FDA-licensed
vaccine for the prevention of anthrax disease.

“Emergent is pleased to have reached an agreement with FDA that now
enables the final steps towards securing approval of Building 55 for
large scale manufacturing of BioThrax. This progress could not have been
achieved without the successful collaboration between the company, FDA,
and BARDA,” said Adam Havey, executive vice president and president,
biodefense division at Emergent BioSolutions. “This multi-year effort to
expand our manufacturing capability is intended to address the U.S.
Government’s stated need for this critical medical countermeasure in the
Strategic National Stockpile. We look forward to our continued
partnership with the government to bring this program to completion.”

The Manufacturing and Non-Clinical Study Protocols reviewed with FDA
specify the criteria by which product manufactured in Building 55 will
be determined as comparable to BioThrax currently produced in Building
12. The company has initiated manufacturing consistency lots of BioThrax
in Building 55 to demonstrate comparability and for use in the pivotal
non-clinical study, which is scheduled to begin this year. Data from
this non-clinical study, together with the comparability data from these
consistency lots, will be used to support a Prior Approval Supplement to
the BioThrax licensed BLA for the approval of Building 55.

Building 12 produces 7 to 9 million doses of BioThrax annually. Building
55 has the potential to triple manufacturing capacity to an estimated 20
to 25 million doses annually. Both facilities are located on Emergent’s
Lansing, Michigan campus.

This program is fully funded under contract number HHSO100201000034C, in
the amount of up to $107 million, provided by the Biomedical Advanced
Research and Development Authority (BARDA) within the Office of the
Assistant Secretary for Preparedness and Response in the U.S. Department
of Health and Human Services.

About Emergent BioSolutions

Emergent BioSolutions is a specialty pharmaceutical company seeking to
protect and enhance life by offering specialized products to healthcare
providers and governments to address medical needs and emerging health
threats. Additional information about the company may be found at www.emergentbiosolutions.com.
Follow us @emergentbiosolu.

BioThrax® and any and all Emergent BioSolutions Inc. brand,
product, service and feature names, logos and slogans are trademarks or
registered trademarks of Emergent BioSolutions Inc. or its subsidiaries
in the United States or other countries. All rights reserved.

Safe Harbor Statement

This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Any
statements, other than statements of historical fact, including
statements regarding our strategy, future operations, prospects, plans
and objectives of management, and any other statements containing the
words “believes”, “expects”, “anticipates”, “intends”, “plans”,
“estimates” and similar expressions, are forward-looking statements.
These forward-looking statements are based on our current intentions,
beliefs and expectations regarding future events. We cannot guarantee
that any forward-looking statement will be accurate. Investors should
realize that if underlying assumptions prove inaccurate or unknown risks
or uncertainties materialize, actual results could differ materially
from our expectations. Investors are, therefore, cautioned not to place
undue reliance on any forward-looking statement. Any forward-looking
statement speaks only as of the date of this press release, and, except
as required by law, we do not undertake to update any forward-looking
statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the company’s
actual results to differ materially from those indicated by such
forward-looking statements, including appropriations for BioThrax®
procurement; our ability to obtain new BioThrax sales contracts or
modifications to existing contracts; our plans to pursue label
expansions and improvements for BioThrax; availability of funding for
our U.S. government grants and contracts; the timing of and our ability
to obtain and maintain approval for Building 55; and our manufacturing
capabilities and strategy. The foregoing sets forth many, but not all,
of the factors that could cause actual results to differ from our
expectations in any forward-looking statement. Investors should consider
this cautionary statement, as well as the risk factors identified in our
periodic reports filed with the SEC, when evaluating our forward-looking
statements.